DeRoyal AMG Suction Connector Tubing connection may fail to seal
DeRoyal Industries is recalling AMG Suction Connector Tubing because the connection between the tubing and suction device may not seal properly, potentially affecting patient care.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of medical device with documented risk of functional failure affecting patient care. No reported injuries or illnesses. Qualifies as high-risk product where injury has not yet been reported per the severity rubric.
Plain-English summary
DeRoyal Industries Inc is recalling approximately 224,770 units of DeRoyal AMG Suction Connector Tubing due to a potential connection failure. The affected products include multiple reference numbers (71-2083, 71-C506, 71-C510, 71-C512, and 71-C520) distributed across multiple U.S. states and Kuwait. Specific affected lot numbers are identified with expiration dates ranging from April 2024 through October 2029.
The tubing may not ensure a tight seal between the connector and the yankauer (suction device), potentially resulting in inadequate suction during patient care. This functional failure could delay necessary patient care in medical settings.
Healthcare facilities, providers, and patients should stop using affected products and contact DeRoyal Industries Inc or their healthcare provider for guidance on replacement or proper disposal. Individuals should verify their product lot numbers against the detailed recall list to determine if their tubing is affected.
No injuries or illnesses related to this defect have been reported.
The recalled product
- Product
- DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 224,770
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 71-2083 Connector Tubing 71-2084 71-C501 Suction Tubing
Distribution
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